Director of Quality Assurance

Director Of Quality Assurance

At Intuitive, we are united behind our mission : we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible. Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves. Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential. Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.

Job Description

General Responsibilities :

• Oversee quality aspects of Intuitive's Fluorescence Imaging program - plan, organize and prioritize work activities based on goals and priorities for QA.
• The candidate will interact with and provide oversight to external Quality consultants as necessary to accomplish programmatic goals. As such, broad knowledge of QA as it pertains to GLP, GCP and GMP is desired.
• Knowledge of ICH and Good Data Practices highly recommended.
• Work closely with the Fluorescence Imaging team (including Document Controls and CMC) and Intuitive's Regulatory and Quality organization to develop and oversee quality activities and ensure that Intuitive's QA standards are met and conform to GCP and GMP regulations.
• Develop, improve, and maintain Quality Management System (QMS) relevant to work performed by Intuitive Fluorescence Imaging, including review and approval of QMS documentation, SOPs, batch record review, and batch disposition.
• Keep up to date with all related quality legislation and compliance issues.
• Utilize guidance documents, international standards, or consensus standards and interpret for guidance.
• Administer the document management system for the department.
• Prepare and assist in annual reports and quality trending reports.
• Monitor, document, and report on the status of the quality levels of, systems and production activities.
• Document internal compliance processes, and prepare materials for submission to regulatory agencies.
• Ensure regulatory rules are communicated through corporate policies and procedures.
• Evaluate quality events, incidents, queries, and complaints.
• Work closely with Intuitive's Quality organization to ensure quality events are thoroughly investigated and product meets Intuitive's quality standards.
• Assist with regulatory inspections and external audits as needed. This includes preparing the staff to establish and maintain adequate processes for hosting regulatory interactions.
• Participate in various cross-functional projects within continuous improvement and new programs.

GMP-related Responsibilities :

GCP-related Responsibilities

Qualifications

Additional Information

Due to the nature of our business and the role, please note that Intuitive and / or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.

Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.

Due to the nature of our business and the role, please note that Intuitive and / or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.

Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

Preference will be given to qualified candidates